# K251517: Encora X1

- Pathway: 510(k) (Traditional)
- Applicant: Encora, Inc.
- Decided: Feb 5, 2026 after 265 days
- Product code: QBC (External Upper Limb Tremor Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5897
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170028 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN170028: Cala ONE, Cala Health, Inc. (2018) Summary page 5.
- K182706: External upper limb tremor stimulator, Cala Health, Inc. (2018) Summary page 5.

## Indications for use
Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.

Source page: https://510kreport.com/device/K251517
Methodology: https://510kreport.com/methodology